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Early-Stage Preclinical Validation of Carbon Monoxide Prodrugs for Acute Kidney Injury

Award Number: R01DK128823
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Early-Stage Preclinical Validation of Carbon Monoxide Prodrugs for Acute Kidney Injury - In response to PAR-19-294 (Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK), we propose to conduct preclinical validation of carbon monoxide (CO) as a therapeutic agent for treating acute kidney injury (AKI), which afflicts a large number of patients with serious and sometimes fatal consequences. Currently, there are no treatment options available other than maintenance therapy. Therefore, developing disease modifying treatment for AKI will address an important, unmet medical need. The proposed work of developing CO-based therapeutics is based on CO’s endogenous signaling roles, the availability of a large amount of literature evidence to show CO’s cyto- and organ-protective effects, our unique chemistry work to pack “CO in a pill” through innovative prodrug design for easy delivery through pharmaceutically acceptable forms, and our own extensive preliminary results in demonstrating the organ-protective effects of such CO prodrugs in animal models of kidney ischemia reperfusion injury and rhabdomyolysis injuries, liver injury, systemic inflammation, and GI inflammation such as the colon and stomach, among others. In this application, we propose to examine some key preclinical validation issues and aim to produce one or more lead compounds ready for IND-enabling work by the end of the grant period. A very important aspect is our plan to use multiple animal models including the examination in large animals such as pig to conduct the pharmacological assessment, which should give enhanced chance of success when translating into human. Specifically, we propose to pursue the following specific aims (1) design, synthesis, and assessment of CO prodrugs, (2) therapeutic validation of CO prodrug efficacy in mouse models of AKI, and (3) therapeutic validation of CO prodrugs in pig models of AKI. The proposed work will bridge the gap between our long-term goal of developing CO-based therapeutics and the need for preclinical assessments. Upon completion of the project, we will have developed and fully validated the efficacy of a series of innovative CO prodrugs that can either deliver CO systemically or selectively target the kidney and allow for renal enrichment. Further, we will also have developed a pipeline for backup candidates. Collectively, the proposed work will be a major step in developing CO-based therapeutics against AKI and other forms of organ injury.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $705,716 )
2025	2025	GEORGIA STATE UNIVERSITY RESEARCH FOUNDATION INC	58 EDGEWOOD AVE NE	ATLANTA	GA	30303	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/16/2025	NON-COMPETING CONTINUATION	$705,716
														Subtotal = $705,716

Issue Date FY: 2024 ( Subtotal = $678,976 )
2024	2024	GEORGIA STATE UNIVERSITY RESEARCH FOUNDATION INC	58 EDGEWOOD AVE NE	ATLANTA	GA	30303	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/8/2024	NON-COMPETING CONTINUATION	$678,976
														Subtotal = $678,976

Issue Date FY: 2023 ( Subtotal = $707,586 )
2023	2023	GEORGIA STATE UNIVERSITY RESEARCH FOUNDATION INC	58 EDGEWOOD AVE NE	ATLANTA	GA	30303	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/21/2023	NON-COMPETING CONTINUATION	$707,586
														Subtotal = $707,586

Issue Date FY: 2022 ( Subtotal = $750,347 )
2022	2022	GEORGIA STATE UNIVERSITY RESEARCH FOUNDATION, INC.	58 EDGEWOOD AVE NE 3RD FL	ATLANTA	GA	30303	FULTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/13/2022	NEW	$750,347
														Subtotal = $750,347

Grand Total All Awards = $2,842,625

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Early-Stage Preclinical Validation of Carbon Monoxide Prodrugs for Acute Kidney Injury

Award Number: R01DK128823

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/15/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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